Removawell Tissue Culture Plate W/Lid

FDA 510(k) K821687 · Dynatech Corp.

Substantially Equivalent

510(k) numberK821687

Submission

Device name
Removawell Tissue Culture Plate W/Lid
Applicant
Dynatech Corp.
Mchenry, IL, US
Received
June 8, 1982
Decision date
June 24, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KIZ – Dish, Tissue Culture
Device class
Class I (low risk)
Regulation
21 CFR 864.2240
Specialty
Hematology

Other 510(k)s with product code KIZ

510(k)DeviceApplicantDecision
K890542Multiwell Culture Plate InsertsKIZ · Traditional Bd Becton Dickinson Vacutainer Systems Preanalytic02/14/1989SE
K873891Tissue Culture DishesKIZ · Traditional Nunc, Inc.11/25/1987SE
K871483Tissue Culture/Bacteriological Petri DishesKIZ · Traditional Isratech Marketing Corp.04/29/1987SE
K854724Cekk-Adhesive Matrix-Multiple Well Plate Cam-PlateKIZ · Traditional Lifetrac, Inc.12/13/1985SE
K853634Corning Cell Wells-Multiple Well PlatesKIZ · Traditional Corning Medical & Scientific09/16/1985SE
K790958120 Well Histo-PlateKIZ · Traditional Dynatech Laboratories, Inc.06/28/1979SE
K781792Pressurizer, Exeter CementKIZ · Traditional Howmedica Corp.02/08/1979SE

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K854602Mini Mash 2000LIB · Traditional 12/06/1985SE
K832117Immulon Substrate Removawell StripsLIB · Traditional 08/08/1983SE
K823787Handi-WashLIB · Traditional 03/09/1983SE
K823833Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional 03/08/1983SE
K830200Microelisa Minireader IILBI · Traditional 02/16/1983SE
K823773Provial II #006-010-0201KDT · Traditional 01/21/1983SE
K823557Removawell Plate LidLIB · Traditional 12/28/1982SE

Questions and answers

When was Removawell Tissue Culture Plate W/Lid cleared by the FDA?

Removawell Tissue Culture Plate W/Lid (K821687) received a 510(k) decision of Substantially Equivalent on June 24, 1982, 16 days after the submission was received.

What is the product code of K821687?

The FDA product code is KIZ – Dish, Tissue Culture, a Class I (low risk) device regulated under 21 CFR 864.2240.